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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Earnings
Nobel Biocare reported 4Q:11 sales of EUR 154.6 million ($200.2 million), flat over the year-ago period and missing estimates by EUR 5.4 million ($7.0 million). The company noted "continued challenging market conditions." Net income for the quarter was EUR 13.3 million ($17.2 million), missing estimates by EUR 4.8 million ($6.2 million).

Funding
Paradigm Spine raised $8.2 million of a planned $14.6 million funding round.

Tenex Health closed an $11.8 million PIPE. Proceeds from which are being used to "fully integrate manufacturing and production capabilities with operations and sales as well as expand our physician and consumer marketing campaigns" for the FAST procedure. Emergent Financial Group acted as the sole placement agent for the transaction, which was part of a reverse merger with U.S.-listed Direct Pet Health Holdings, Inc. FAST, an acronym for Focused Aspiration of Scar Tissue, is designed for the treatment of tendon injuries.

Regulatory
Baxano received a medical device license from Health Canada, permitting the company to market the iO-Flex System for spinal decompression surgery throughout Canada. The iO-Flex is described as the "first minimally invasive set of flexible instruments designed to target lumbar stenosis in the central canal, lateral recess and neural foramen."

Medicrea received 510(k) clearance for the PASS MIS system and announced the first U.S. surgery using the device, which was completed in Doylestown Hospital in Pennsylvania. The system features a "polyaxial posted screw and top loading connector design."

Wright Medical received 510(k) clearance and initiated a limited launch of the PROPHECY INBONE Pre-Operative Navigation Alignment Guides for use with the company's INBONE Total Ankle Replacement Systems. A full U.S. commercial release is expected to take place in 2H:12.

Product Introduction & Update
Biomet Orthopedics launched the Signature Personalized Patient Care System, which enables a surgeon to preoperatively plan a partial knee replacement and delivers custom positioning guides for use with the Oxford Partial Knee System.

BioMimetic Therapeutics launched the Augmatrix Biocomposite Bone Graft, which consists of calcium phosphate and Type I collagen. It is designed to be combined with bone marrow aspirate and is available in multiple forms, with potential indications including fracture repair and general bone void filling procedures.

CONMED launched the Hip Preservation System, which "[provides] comprehensive instrumentation and technique solutions for hip joint preservation"; the Y-KNOT 1.3mm All-Suture Anchor, which the company calls the smallest "all-suture" anchor on the market; the PressFT Suture Anchor, available in PEEK and biocomposite variants; the XACTPIN Graft Passing Guide Pin for use in soft tissue repairs; allografts for sports medicine, pursuant to their agreement with MTF; Cascade Platelet Rich Plasma Therapy; as well as several additions to its powered surgical instruments portfolio, namely a lithium battery system and new blades.

DePuy announced the launches of the AOX Antioxidant Polyethylene, RECLAIM Modular Revision Hip System, GRIPTION TF Acetabular Augment System, GLOBAL UNITE Platform Shoulder Arthroplasty System and GLOBAL STEPTECH Anchor Peg Glenoid (APG). DePuy is also introducing the latest generation of TRUMATCH Personalized Solutions technology for use with its SIGMA Fixed-Bearing Knee System.

Exactech announced the full market launch of the Optetrak Logic primary knee system; the launch of the Optetrak Logic CR, which "enables surgeons to plan and perform a CR total knee replacement based on the anatomical and functional integrity" of the PCL; the availability of the Novation Crown Cup featuring a new porous titanium alloy called InteGrip; the launch of the Equinoxe Augmented Glenoid implants for "challenging glenoid morphologies"; the full market launch of Gibralt cervical thoracic spine system; the introduction of the ART II protocol, which combines tranexamic acid with PRP in total knee surgery; the introduction of the Ossigen, a 3D matrix of collagen and an organic bone mineral processed into blocks; the full market release of a smaller InterSpace shoulder; and the full market release of the 40g Cemex System Fast with Gentamicin.

Integra LifeSciences launched the Integra Allograft Wedge System, which the company says consists of "pre-cut allograft wedges for both Evans and Cotton osteotomies" as well as an instrumentation set designed to aid the surgeon in selecting the appropriate wedge.

Invuity launched the illuminated Eigr Taylor Retractor System, which is designed to "enhance visualization and tissue retraction during spinal surgery."

MiMedx launched AmnioFix Injectable, an allograft composed of micronized amniotic tissue designed to reduce inflammation at the injection site and enhance soft tissue healing in trauma and sports medicine procedures.

OrthAlign launched the KneeAlign 2 System for distal femoral and tibial resection in Total Knee Arthroplasty.

Orthofix launched the Galaxy Fixation, an external fixation system designed for use in temporary and definitive complex orthopedic trauma applications. The company also introduced the Centronail Ankle Compression Nailing System for hindfoot fusions and the Contours Lapidus Plating System for revision procedures and joint fusion in the small bones of the midfoot.

RTI Biologics launched two new allograft products at AAOS this week: the BioAdapt DBM, described as a flexible demineralized bone matrix available as a room-temperature implant in five pre-shaped options, and the fresh-stored OC Humeral Head allograft, which "enables surgeons to resurface osteochondral defects with mature hyaline cartilage and healthy subchondral bone in a single procedure." The company also highlighted their educational website AllograftInfo.com.

SurgLine announced that they supplied their first spinal implants for a spine surgery at the end of January. Spine and Joint Solutions was the distributor for the procedure. Based in Southern California, SurgLine is focused on reducing costs for spinal procedures.

TeDan Surgical Innovations launched the Phantom Series MIS Anterior Hip Retractor, which the company says features adjustable surgical arms with attachable retractors that enable surgeons to perform the entire anterior hip replacement procedure without a fracture table or a surgical assistant.

Tornier highlighted the following products at AAOS: the Aequalis Ascend Shoulder, launched last year, an MIS system designed to minimize bone loss; the Latitude II Total Elbow System, in limited release in the U.S.; the RFS Cannulated Screw System, in limited release in the U.S., used in foot procedures; the Insite FT Anchor Family; the Duo Soft Tissue Fixation System, which features an anchor that can be used in either a tied or knotless fashion; the ArthroPass Suture Passer, in limited release in the U.S.; the SoloStitch Graft Preparation Kit, in limited release in the U.S.; the QuickCell Platelet Concentrate System; and the LIFT and STRIDE Patient Education Programs, designed to increase public awareness of treatment options for chronic shoulder and ankle pain.

Zimmer launched personalized surgical cutting guides for partial knee replacement procedures; the Universal Power System and STABLECUT line of surgical saw blades; and an iPad app called Arthritis 411, a free patient education app.

Intellectual Property
ConforMIS announced that 22 patents have been issued to the company since January 2011, bringing the company's total of owned or licensed patents in excess of 50. The patents cover patient-specific implants and patient-specific instrumentation systems with applications in knee, hip, shoulder, small joint and spine.

OrthoSensor received two new U.S. patents, entitled "Method and system for enhancing accuracy in ultrasonic alignment" and "Post-operative pain inhibitor for joint replacement and method thereof." The company is developing a sensor-based portfolio with applications for soft tissue balancing, mechanical alignment, intelligent implants and evidence-based analytics.

Investigations
Fourteen hospitals in New York, Mississippi, North Carolina, Washington, Indiana, Missouri and Florida will pay the U.S. government more than $12.0 million to settle allegations that they submitted false kyphoplasty claims to Medicare. With the addition of these 14 hospitals, more than 40 centers have settled similar allegations with the government.

Orthofix announced the resolution of three separate legal matters. The company agreed to pay $32 million to settle a U.S. Attorney's investigation into Blackstone Medical, settle a federal investigation into alleged violations of the Foreign Corrupt Practices Act and resolve of a criminal and civil probe relating to the company's bone growth stimulation business. As part of the resolution of these matters, Orthofix expects to enter into a five-year Corporate Integrity Agreement (CIA) with the OIG.

Smith & Nephew will pay $22.2 million to settle alleged violations of the Foreign Corrupt Practices Act relating to business practices in Greece. BusinessWeek reports that the company disclosed in federal court filings that "two of its units were involved in a scheme for more than a decade to make 'illicit payments' to doctors employed by government hospitals or agencies in Greece." The company will pay a $16.8 million fine to settle the criminal allegations and another $5.4 million to settle a civil suit filed by the SEC.

Clinical
Zimmer and ISTO Technologies announced plans to enroll up to 225 patients at 25 sites in a new phase III study, which will compare the use of the DeNovo ET Engineered Tissue Graft to microfracture for the repair of cartilage defects in the knee.

Operations
Corentec launched Corentec America, a wholly owned subsidiary of the Seoul-based company that will offer hip, knee and spine products to the U.S. market.

Collaborations
The American Joint Replacement Registry announced IT updates relating to its joint registry: Remedy Informatics will build a registry, and InVivoLink will provide registry data acquisition tools to the AJRR.

Stryker announced that they have selected WebOps Logistics to provide inventory management services for their U.S. orthopedics field network. Rollout will begin immediately.

Appointments
Stryker Chairman, President and CEO Stephen MacMillan stated that he will resign his post for family reasons. Stepping in as interim CEO will be VP and CFO Curt Hartman, with William Parfet, currently Lead Independent Director, appointed Non-Executive Chairman. The company will consider both internal and external candidates in searching for a permanent CEO.

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